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7th April 2021
30 March 2021: MHRA added new information on the inspector providing a verbal summary of GLP monitoring inspection findings:
After the initial implementation inspection, a test facility can expect to be inspected every 12 to 30 months. The UK GLPMA normally gives at least 10 working days’ notice.
There will be some circumstances when the inspection may be unannounced or at short notice. Monitoring inspections involve:
You must keep verified copies of any returned study reports and associated raw data for a minimum of 2 years or 1 inspection cycle.
At the end of the inspection the inspector will give you a verbal summary of the inspection findings and allow you the opportunity to correct any misunderstandings.
Also added a link to a new page on responding to a GLP and GCP laboratory inspection report.